Vadim Klyushnichenko of The Scripps Research Institute works with some 10 CDMOs at any given time. He's developed methodologies for handling due diligence, project and product quality for both drug substance and drug product, and timelines and budgets. But perhaps most instructive is his management — and best practices — for handling all the analytical services his programs require through development and manufacturing at his service providers.
The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.
Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.
Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
Trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.
Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
A small, oncology-focused biotech was experiencing significant data, safety, vendor and monitoring issues in its Phase I programs that were worsening with time.
Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.
I first met Mark Bamforth, the president and CEO of Gallus BioPharmaceuticals, at a conference shortly after he had acquired/founded his CMO in St. Louis. The company was so new many of the employees at the event didn’t even have business cards.
L.E.K., founded in 1983, is a global strategy consulting firm with offices across Europe, the Americas, and Asia-Pacific. One of its more than 900 employees, Jonathan Kfoury, functions as the VP of L.E.K.’s Boston office, with a focus on R&D, partnership, and commercialization strategy development for biopharmaceutical and medical technology companies. By Rob Wright
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Many biologics companies will partner with a contract development and manufacturing organization that can provide the required expertise and resources as well as flexibility of operations.
Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market.
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
